Clinical trial NCT01391065: MR- PET Guided Biologically Optimised Interstitial Brachytherapy
Official title: MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Diffusion Weighted MRI
FLT PET
F-Miso PET
Image Guided Brachytherapy
Cervix
Postoperative Residual Disease/Postoperative recurrences
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2011-07-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).

The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.

In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.

Detailed description: Aims

Stage I

Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.

Stage II:

Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.

Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* ECOG 0 or 1.
* Residual/ Recurrent tumor after hysterectomy of cervical cancer.
* No visceral metastasis.
* No known contraindication to contrast enhanced MRI/PET scan.
* Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion Criteria:

* Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
* Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).

Primary outcomes:
measure: Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
timeFrame: 3 months after treatment completion
Secondary outcomes:
measure: Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy
timeFrame: 2 years after treatment conclusion
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
state: Maharashtra
Study officials:
References:
citation: Chopra S, Engineer R, Shah S, Shukla R, Dora T, Gupta P, Paul SN, Popat P, Swamidas J, Mahantshetty U, Varghese L, Gupta S, Rangrajan V, Shrivastava S. MRI- and PET-Guided Interstitial Brachytherapy for Postsurgical Vaginal Recurrences of Cervical Cancer: Results of Phase II Study. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):310-319. doi: 10.1016/j.ijrobp.2019.10.037. Epub 2019 Nov 1.