Trial looking at different treatments to intensify treatment in oropharyngeal cancer.

Phase 3

• Conditions: Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecifiedHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2021/03/031884
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Oropharyngeal squamous cell carcinoma (OPSCC) in base of

tongue and tonsil (includes bilateral tumours) with a

Multidisciplinary Team (MDT) recommendation for treatment with

definitive concurrent chemoradiotherapy

2. All OPC T4 or N3 (HPV-pos and HPV-neg)

OR

all HPV-neg OPC T1-T4, N1-N3 or T3-4, N0

OR

HPV-pos OPC T1-T4 with N2b-N3 nodes AND who are smokers

>= 10 pack years current or previous smoking history

3. Minimum life expectancy of 3 months

4. Eastern Cooperative Oncology Group (ECOG) performance

status 0-1

5. Body weight of >30kg

6. Adequate renal function, estimated glomerular filtration rate

(eGFR) >50ml/min calculated using Cockcroft-Gault formula

7. Adequate bone marrow function (absolute neutrophil count (ANC)

>=1.5 x 109/L, haemoglobin >=9.0g/dL and platelets >=100 x 109/L)

8. Adequate liver function i.e. serum bilirubin <=1.5 times the upper

limit of normal (ULN), AST (SGOT)/ALT (SGPT) <=2.5 x

institutional upper limit of normal

9. Prothrombin time (PT) <=1.5 x ULN or International Normalised

Ratio (INR) <=1. 5

10.Magnesium >= lower limit of normal

11. No cancers in previous 5 years, except basal cell carcinoma of

skin and cervical intra-epithelial neoplasia (CIN)

12. Aged 18-70

13. Written informed consent given for the trial

14. Surgically resectable disease if being randomised to all four arms

15.Evidence of post-menopausal status or negative urinary or serum

pregnancy test for female pre-menopausal patients. Women will

be considered post-menopausal if they have been amenorrheic

for 12 months without an alternative medical cause. The following

age-specific requirements apply:

- Women <50 years of age would be considered postmenopausal

if they have been amenorrheic for 12 months

or more following cessation of exogenous hormonal

treatments and if they have luteinizing hormone and

follicle-stimulating hormone levels in the post-menopausal

range for the institution or underwent surgical sterilization

(bilateral oophorectomy or hysterectomy).

- Women >=50 years of age would be considered postmenopausal

if they have been amenorrheic for 12 months

or more following cessation of all exogenous hormonal

treatments, had radiation-induced menopause with last

menses >12 months ago, had chemotherapy-induced

menopause with last menses >12 months ago, or

underwent surgical sterilization (bilateral oophorectomy,

bilateral salpingectomy or hysterectomy).

16. Willingness to comply with the protocol for the duration of the

study, including undergoing treatment and scheduled visits and

examinations including follow up

Exclusion Criteria

Entered in the Brief Summary section(last page of CTRI form ) due to repeated errors in accepting data in the Exclusion criteria section.

Study & Design

• Study Type: Interventional
• Study Design: Not specified