Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
Brief Summary: Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer1. Whilst it has no proven impact on overall survival it significantly increases local control.

Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.

Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.

Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.

There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.

By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.


Options:
A: Inclusion Criteria:

* Patients undergoing adjuvant pelvic radiotherapy for histologically confirmed endometrial adenocarcinoma / serous carcinoma / papillary serous carcinoma / mixed histology (adenocarcinoma and serous) and following AJCC 2009 grade/stage:

  * Grade 2: stage IB (LVSI +/or \>60yrs)
  * Grade 3: stage IA and IB
  * Grade 1-3: Stage II and IIIA, IIIB and IIIC1
* Surgery consisting of total hysterectomy, +/- bilateral salpingo-oophorectomy, +/- lymph node sampling
* Staging with imaging of pelvis and abdomen (either MRI or CT)
* ECOG PS 0-2
* Age ≥ 18 years
* Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

* Previous radiotherapy to the pelvic region
* Patients in whom concurrent chemotherapy in planned
* Patients with macroscopic disease in situ
* History of inflammatory bowel disease
* Previous hip replacement
* Previous bowel surgery (excluding appendectomy)
* Patients with other syndromes/conditions associated with increased radiosensitivity
* The patient has or had other co-existing malignancies within the past 5 years other than non-melanoma skin cancer
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
B: DISEASE CHARACTERISTICS:

* Histologically confirmed cancer in the pelvis
* Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)

  * Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)
  * Portions of rectum may have special blocking depending on disease site
  * Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)
  * No planned split-course radiotherapy
  * No planned interstitial brachytherapy prior to completion of external-beam radiotherapy
  * Planned intracavitary radiotherapy allowed
  * No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin
  * Entered on study before the third radiotherapy fraction
* No current or prior metastases beyond pelvic or para-aortic lymph nodes
* No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy
* No incontinence of stool

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Renal:

* No chronic renal failure
* Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergy to octreotide
* No history of inflammatory bowel disease
* No other concurrent medical condition that would preclude study participation
* No history of cholecystitis unless prior cholecystectomy

PRIOR CONCURRENT THERAPY:

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to the pelvis

Surgery:

* See Disease Characteristics
* No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum
C: Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

* treatment with radiotherapy
* age ≥ 18 years of age
* Ability ability of subject to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

Patients presenting with any of the following criteria will not be included in the trial:

* any contraindication to acupuncture
* known coagulopathy or anticoagulation therapy with bleeding time \> 4 minutes, thrombocyte count \< 50 000/μl
* missing compliance
* skin disease in the region of the acupuncture points
* refusal of the patients to take part in the study
* participation in another clinical study or observation period of competing trials,
D: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Clinical stage T1b-T3c disease
  * No clinical or radiographic evidence of metastasis
* Prostate-specific antigen (PSA) less than 80 ng/mL
* Gleason score at least 5
* One of the following criteria must be met:

  * PSA greater than 10 ng/mL
  * Gleason score greater than 6
  * T2b or greater palpable disease
  * Three or more biopsy cores involved with a Gleason score of at least 5

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other medical condition that would preclude study participation
* No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* No more than 4 months of prior androgen deprivation therapy
* Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only

Radiotherapy

* No prior pelvic radiotherapy

Surgery

* No prior or planned radical prostate surgery

Answer: A