Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial

NCT05144100 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 3582
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

The oropharyngeal areas mainly comprises of the tonsil, base tongue (BOT), soft palate and the posterior pharyngeal wall. Traditionally, surgical resection of oropharyngeal cancers (OPC) was a standard procedure, often performed through mutilating incisions with mandibulotomies, rendering significant post-operative functional deficits. Over the past 2 decades, there has been a major shift in treatment strategy with a majority of these cancers now being treated by primary concurrent chemoradiation (CCRT) with a trend towards organ and function preservation.

Conditions

Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (2)

• Event Free Survival.(EFS)

  Event Free Survival will be defined as the time between the date of randomization till the date of recurrence of the disease (either local, regional or distant failure) or death due to disease.

  5 years after completion of last participant enrollment

• Overall Survival (OS)

  Overall Survival (OS) will be defined as the time between the date of randomization and the date of death due any cause

  5 years after completion of last participant enrollment

Secondary Outcomes (6)

• Disease free survival (DFS)

  5 years after completion of last participant enrollment

• Progression free survival (PFS)

  5 years after completion of last participant enrollment

• Locoregional control (LRC)

  5 years after completion of last participant enrollment

• Subjective Swallowing function

  After 1 year (short term) and after 3 years(long term) from the date of enrollment

• M.D. Anderson Dysphagia Inventory Head and neck cancer-specific quality of life and patietn reproted outcomes (QOL and PROs)

  After 1 year (short term) and after 3 years(long term) from the date of enrollment

Study Arms (2)

Arm 1 - Surgery +/- Neck Dissection

EXPERIMENTAL

Patients would undergo appropriate surgery via open, endoscopic, TLM, TORS or a combination. The primary and the neck would be addressed. For N0 neck, clearance of levels II-IV will be required, with levels I and/or V electively dissected at the discretion of the operating surgeon and based on extension of nodal disease. For N+ neck and tumors approaching to within 1cm of the midline, we recommend a contralateral neck dissection be performed as well of levels II-IV but to be done as per operating team's discretion. For lateralized lesions of the BOT and tonsil, ipsilateral neck dissection will be performed. A minimum of 18 lymph nodes per dissected side of the neck is required and will be subject to quality assurance review

Procedure: Surgery with or without Neck Dissection

Arm 2 - Chemoradiation

EXPERIMENTAL

Patients will receive IMRT with normal tissue sparing techniques (70Gy/35# or 66Gy/ 30#) along with concurrent weekly cisplatin. Weekly cisplatin will be administered during IMRT at a dose of 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36, and 43 for a total of up to 7 weekly doses, administered during the course of IMRT. For patients with T1-2 lateralized tonsil tumors with \<1 cm invasion into the soft palate, no invasion of BOT, and N1 neck involvement, unilateral neck will be irradiated. The contralateral neck will be addressed for some BOT tumors\<1cm or at the midline and may be considered in patients with N2 and N3status. For patients with residual neck disease after CCRT, a formal neck dissection will be performed. For patients with residual primary disease after CCRT, surgery for the primary will be performed if feasible.

Radiation: Radiation; Drug: Cisplatin based chemotherpay

Interventions

Surgery with or without Neck Dissection PROCEDURE

An appropriate surgery as open, endoscopic, TLM, TORS or a combination with or without neck dissection e.g. levels dissected, sparing or sacrifice of the SCM, accessory nerve, etc as per patient disease and status will be performed

Also known as: appropriate surgery as open, endoscopic, TLM, TORS or a combination with or without neck dissection

Arm 1 - Surgery +/- Neck Dissection

Radiation RADIATION

Patients will receive IMRT with normal tissue sparing techniques (70Gy/35# or 66Gy/ 30#) along with concurrent weekly cisplatin. Weekly cisplatin will be administered during IMRT at a dose of 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36, and 43 for a total of upto 7 weekly doses, administered during the course of IMRT.

Also known as: Radiotherapy with IMRT with normal tissue sparing techniques

Arm 2 - Chemoradiation

Cisplatin based chemotherpay DRUG

Cisplatin (dose-40 mg/m2weekly,upto6-7cycles) cycle 1 will be administered within first 2 # of radiation. The rest of the cycles will be given weekly.

Arm 2 - Chemoradiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and/or lateralized tongue-base
• ECOG Performance Status ≤2
• Age ≥18 to 70 years
• Anesthetic fitness obtained for surgery under general anesthesia
• Resectable primary tumor with an anticipation of achieving resection free margins either by minimally invasive/open techniques
• Clinical stage III or IV, i.e. T1-T2 or T3-T4 with N0-N3. Nodal disease withextranodal extension on clinical examination/imaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon
• HPV negative status determined by p16 status.
• No distant metastases below the clavicles, based upon the following minimum diagnostic workup:
• History/physical examination by the physician.
• Imaging of the head and neck (Contrast enhanced MRI for local workup and Chest CT/PET-CT for distant metastatic workup)
• Patients with no contraindications to Cisplatin chemotherapy and radiotherapy
• Adequate organ function
• Hematological- Hb\> 10 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.
• Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT/ ALP ≤ 2.5 x ULN, S. albumin ≥ 30 g/L.
• Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \> 50 mL/min.

You may not qualify if:

• Prior head and neck malignancy
• Prior invasive malignancy, unless disease free for a minimum of 3 years
• Prior chemotherapy for a different cancer administered within 3 years prior to registration
• Patients who have received any neoadjuvant/ induction chemotherapy
• Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
• Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
• Large soft palate involvement \>1 cm
• Deep extension into larynx, pre-epiglottic space and deep invasion into extrinsic muscles of tongue
• Calculated GFR \< 50 cc/min
• Patients who have uncontrolled cardiac comorbidity
• QTc prolongation (a value of \>450 milliseconds)
• Ejection fraction below 50%
• Presence of regional wall akinesia
• Presence of previous episode of thrombosis or embolism or presence of a prothrombotic condition in last 1 year
• Presence of severe malnutrition as defined by body mass index of below 16kg per m2 or presence of weight loss of greater than 20% in last 6 months

Sponsors & Collaborators

• Tata Memorial Centre: lead
• All India Institute of Medical Sciences: collaborator
• Amrita Institute of Medical Sciences & Research Center: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

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MeSH Terms

Conditions

Carcinoma

Interventions

Surgical Procedures, Operative; Neck Dissection; Endoscopy; Radiation; Radiotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Otorhinolaryngologic Surgical Procedures; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Physical Phenomena; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Deepa Nair, MS(ENT),DNB

  Tata Memorial Hospital, Mumbai, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepa Nair, MS(ENT),DNB

CONTACT

9820901792; drdeepanair78@gmail.com

Sarbani Ghosh-Laskar

CONTACT

9820834386; sarbanilaskar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Surgical Oncology

Model Details: There will be two groups/arms in the study to evaluate the efficacy of primary surgery versus primary chemoradiation. Participants will be assigned to one of two or more groups for the duration of the study

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: December 3, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2031
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)