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Cancer CervixPhase 3PARCERNCT01279135

Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

A Phase 3 study testing Conventional Radiation and Tomotherapy based IGRT in people with Cancer Cervix, run by Tata Memorial Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer Cervix
What is being tested?
Conventional Radiation and Tomotherapy based IGRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteIndia
Study dates
1 Jan 2011to 5 May 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features.
  • Age >18 years.
  • Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET imaging+/- confirmatory nodal biopsy.
  • No evidence of paraaortic nodal metastasis.

Who cannot join

  • History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder.
  • Rectal Polyps or extensive hemorrhoids.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

    Navi Mumbai, Maharashtra, 410210

Other trials in India

About this study

Official title: Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.

Read the detailed description

Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity

Conditions
Cancer Cervix
Being tested
Conventional Radiation, Tomotherapy based IGRT
Keywords
IGRT,Postoperative, Cervix, Late toxicity, Bowel
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional RadiationRadiation

    Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

  • Tomotherapy based IGRTRadiation

    Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks

Study groups in NCT01279135
Study groupRoleWhat they receive
Conventional RTActive comparatorPatients in this arm will receive conventional radiation with or without chemotherapy
Receives: Radiation: Conventional Radiation
Tomotherapy based IGRTExperimentalPatients in this arm will receive Tomotherapy based IGRT with or without chemotherapy
Receives: Radiation: Tomotherapy based IGRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late bowel toxicity ≥ Grade II

    Time to event and severity of late bowel toxicity are assessed

    Measured: Median follow up of 3 years

Secondary outcomes (5)

  1. To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity

    Data on dosimetric analysis of small bowel dose in reference to volume are collected in both arms and assessed for predicting dose prescription for ≥ grade II late bowel toxcity

    Measured: Median follow up of 3 years

  2. To evaluate acute toxicity difference in two study arms using CTCAE version 3.0

    Acute toxicity will be reported using CTCAE V.3.0. CTCAE forms will be filled before starting radiation, weekly during radiation treatment and on each scheduled follow-up. If any toxicity occurs at another time point additional forms will be filled to capture the same. Acute toxicity difference will be calculated between the two study arms.

    Measured: Within 90 days

  3. Preoperative functional imaging features that predict for local and distant recurrence will be identified

    Images acquired pre-operatively are analysed for features that predict local and distant recurrence.

    Measured: 3 years after completion of accrual

  4. To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30

    Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation . EORTC QLQC30 module will be used for evaluating QOL of patients. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up. Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

    1 will be considered as better outcome \& 4 will be considered as worst outcome.

    Measured: 3 years from completion of accrual

  5. To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24

    Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation. EORTC QLQCX24 module will be used to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. CX24 QOL scoring will be done as per standard recommendations outlined in EORTC QLQ CX24 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up.

    Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

    1 will be considered as better outcome \& 4 will be considered as worst outcome.

    Measured: 3 years from completion of accrual

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study start1 Jan 2011
  3. Primary completion30 Dec 2019
  4. Study completion5 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients enrolled are randomized to either conventional arm or tomotherapy arm for treatment after stratification according to type of surgery the patient underwent and the indication of chemotherapy along with radiation
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01279135
Sponsor's protocol ID
Project 803
Acronym
PARCER
Status last verified
Jan 2026
First submitted
18 Jan 2011
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Chopra S, Engineer R, Mahantshetty U, Misra S, Phurailatpam R, Paul SN, Kannan S, Kerkar R, Maheshwari A, Shylasree Ts, Ghosh J, Gupta S, Thomas B, Singh S, Sharma S, Chilikuri S, Shrivastava SK. Protocol for a phase III randomised trial of image-guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy for late small bowel toxicity reduction after postoperative adjuvant radiation in Ca cervix. BMJ Open. 2012 Dec 12;2(6):e001896. doi: 10.1136/bmjopen-2012-001896. Print 2012.

    PubMed 23242243

  • Supriya C, Nilesh R, Mayuri C, Sadhana K, Reena E, Tapas D, Lavanya G, Prachi M, Amita M, Shylasree TS, Shyam S, Sudeep G. Late toxicity within a Phase III clinical trial of IG-IMRT in cervix cancer (PARCER): Reanalysis with time weighted adverse event reporting (MOSES). Radiother Oncol. 2022 Dec;177:16-20. doi: 10.1016/j.radonc.2022.10.013. Epub 2022 Oct 18.

    PubMed 36270474

  • Chinnachamy AN, Chopra S, Krishnatry R, Kannan S, Thomas B, Mahantshetty U, Engineer R, Shrivastava SK. Evaluation of interobserver and interscale agreement in assessing late bowel toxicity after pelvic radiation in patients with carcinoma of the cervix. Jpn J Clin Oncol. 2013 May;43(5):508-14. doi: 10.1093/jjco/hyt028. Epub 2013 Mar 20.

    PubMed 23515269

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conventional Radiation and Tomotherapy based IGRT in people with Cancer Cervix, run by Tata Memorial Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late bowel toxicity ≥ Grade II (time frame: Median follow up of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279135, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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