Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Brief Summary: RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.


Options:
A: Inclusion Criteria:

* Written informed consent prior to any study activities
* Age 18-75 years old
* Histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
* Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, UICC 2002), resectable lesions
* Karnofsky performance status (KPS) \> 60
* Adequate hematologic function: white blood cell \> 3,000/mm\^3, hemoglobin \> 8g/L, platelet count \> 80,000/mm\^3
* Hepatic function: ALAT/ASAT \< 2.5 times the upper limit of normal (ULN), bilirubin \< 1.5 times ULN
* Renal function: serum creatinine \< 1.5 x ULN
* Life expectancy ≥ 6 months

Exclusion Criteria:

* Evidence of distant metastatic disease and other cancers
* Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
* Previous radiotherapy for the primary tumor or lymph nodes
* Prior chemotherapy or immunotherapy for the primary tumor
* Other previous malignancy within 5 years
* Systematic diseases history of severe pulmonary or cardiac diseases
* Creatinine Clearance \< 30 ml/min
* Legal incapacity or limited legal capacity
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period
B: Inclusion Criteria:

* age 18 or older
* willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Tumour stage:T1 or T2, with likely negative resections at surgery
* Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging.
* Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Metastatic disease
* Inability to attend full course of radiotherapy or follow-up visits
* Neck disease with unknown primary site
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
* unable or unwilling to complete QoL questionnaires
C: Inclusion Criteria:

1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
3. No history of a prior malignancy in the head and neck region.
4. No prior malignancy outside the head and neck region in the preceding 5 years.
5. Patient will be reliable for follow-up
6. Age\> 18 years and \< 75 years.
7. No significant co-morbid conditions - ASA grade II and I.
8. Understands the protocol and is able to give informed consent.

Exclusion Criteria:

1. Prior radiotherapy or surgery for malignancy in the head and neck region.
2. Non squamous cell carcinomas of the oral cavity.
3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.
D: DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

  * Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
* No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 mg/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal

* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 50 mL/min
* Calcium normal

Cardiovascular

* No symptomatic coronary artery disease (angina)
* No myocardial infarction within the past 6 months

Other

* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* No simultaneous primary tumors
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

* No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease

  * No radical or modified neck dissection

Answer: D