Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

NCT06926543 | Recruiting Phase 3 DMC

• 2 other identifiers: 4131CTRI/2023/06/054280
• Study Type: interventional
• Target: 858
• Locations: 1 country
• Sites: 5

Brief Summary

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions:

1. 1.When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
2. 2.What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
3. 3.What are each treatment approach's financial costs?
4. 4.Get the usual chemotherapy (taxanes and/or anthracyclines).
5. 5.Receive radiation therapy for three to four weeks.
6. 6.Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Conditions

Invasive Breast Cancer; Stage III Breast Cancer; Stage IIB Breast Cancer

Keywords

Invasive breast cancer; Chemoradiation; Sequential; Concurrent; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Study the 3-year Disease Free Survival.

  From enrollment to 3 years after treatment at six months intervals.

Secondary Outcomes (6)

• Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.

  From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.

• Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.

  From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.

• The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.

  From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.

• To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods

  From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years

• Overall survival (OS)outcome assessment in the two arms.

  From enrollment to 5 years after treatment at 6 months intervals

Study Arms (2)

Arm A: Standard Arm

ACTIVE COMPARATOR

Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy

Drug: Chemoradiation

Arm B: Experimental arm

EXPERIMENTAL

Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy

Drug: Chemoradiation

Interventions

Chemoradiation DRUG

This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner

Arm A: Standard Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed invasive breast cancer
• Stage IIB-III invasive breast cancer (AJCC 8th edition)
• Patients planned for adjuvant chemotherapy and adjuvant radiotherapy
• Patients fit to receive adjuvant chemotherapy and radiotherapy
• Age \> 18 years

You may not qualify if:

• Hypersensitivity to taxanes
• Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
• Unable or unwilling for regular follow up
• Bilateral tumour needed RT to both sides
• Patients planned for RT to oligometastatic sites
• Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
• Pregnant patient

Sponsors & Collaborators

• Dr. Tabassum Wadasadawala: lead

Study Sites (5)

Homi Bhabha Cancer Hospital & Research Centre

Vishkhapatnam, Andhra Pradesh, 530053, India

NOT YET RECRUITING

Tata Memorial Centre

Mumbai, Maharasthra, 400012, India

RECRUITING

Homi Bhabha Cancer Hospital and Research Centre

New Chandigarh, Punjab, 140901, India

NOT YET RECRUITING

Homi Bhabha Cancer Hospital, Sangrur

Sangrur, Punjab, 148001, India

NOT YET RECRUITING

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, Uttar Pradesh, 221005, India

NOT YET RECRUITING

Related Publications (1)

• Wadasadawala T, Anup A, Carlton J, Sarin R, Gupta S, Parmar V, Pathak R, Ghosh J, Bajpai J, Gulia S, Krishnamurthy R. CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study. Ecancermedicalscience. 2023 Feb 23;17:1510. doi: 10.3332/ecancer.2023.1510. eCollection 2023.

  PMID: 37113709 BACKGROUND

Related Links

• A Pilot Study of CONcurrent ChEmotherapy and RadioTherapy in Adjuvant Treatment of Breast Cancer (CONCERT)

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Tabassum Wadasadawala, MD, DNB Radiotherapy

CONTACT

(+91-22) 24177026; drtabs.radonc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Radiation oncologist

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 13, 2025
• Study Start: May 14, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5)